510(k) K972302
K972302 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "POCKET COUNT OR SAFETCOUNT". The FDA issued a decision of Substantially Equivalent on July 25, 1997. The device falls under product code LWH (Counter, Sponge, Surgical), a Class I device regulated under 21 CFR 880.2740. Sage Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 1997
- Date Received
- June 19, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Sponge, Surgical
- Device Class
- Class I
- Regulation Number
- 880.2740
- Review Panel
- SU
- Submission Type